Journal ArticleOpen Access
Template protocol for clinical trials investigating vaccines—Focus on safety elements
Author Affiliations
Boston Children's Hospital, University Children’s Hospital Basel, Vienna Vaccine Safety Initiative, Children's Hospital of Los Angeles, ...
Published InVaccine
Year2013
Citations23
Abstract
This document is intended as a guide to the protocol development for trials of prophylactic vaccines. The template may serve phases I-IV clinical trials protocol development to include safety relevant information as required by the regulatory authorities and as deemed useful by the investigators. This document may also be helpful for future site strengthening efforts.
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